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Sponsor declined further support
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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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In this study the investigators will assess the ability of Natalizumab, a medication given to treat multiple sclerosis (MS), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (BBB).
The investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwRRMS) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and selective inversion recovery quantitative magnetization transfer imaging (SIR-qMT). pwRRMS will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. Changes in ktrans, a measure of BBB permeability derived from DCE-MRI, and in pool saturation ratio (PSR) a measure of myelin integrity derived from SIR-qMT will be computed to assess the ability of natalizumab to fully restore BBB integrity.
As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Single Arm | Other | SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab 300 MG in 15 ML Injection | Drug | Disease modifying agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans | To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR) | To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Natalizumab on Questionnaire Derived Measures of Quality of Life | To explore changes in QoL measurements and the relations between these changes and those seen in ktrans and natalizumab serum levels. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesca Bagnato, MDPhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37215 | United States |
Upon reasonable request from qualified investigators the PI will release all data listed below.
[per PDBP policy]
[per PDBP policy]
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Single Arm | SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV Natalizumab 300 MG in 15 ML Injection: Disease modifying agent |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Single Arm | SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV Natalizumab 300 MG in 15 ML Injection: Disease modifying agent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans | To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan | Data analysis was not completed because only one participant completed (each arm) and disclosing data could violate privacy interests. | Posted | 12 months |
|
|
At baseline, month 3 and month 12.
Adverse events were collected and reviewed by the PI
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Single Arm | SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV Natalizumab 300 MG in 15 ML Injection: Disease modifying agent |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalizumab and chronic Blood Brain Barrier Breakdown | Vumc | 6159360060 | francesca.r.bagnato@VUMC.ORG |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2021 | Mar 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Open-label, prospective longitudinal study.
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR) | To measure changes in PSR between baseline (pre-treatment) and month-3 and month-12 post-treatment scan | Data analysis is not reported because only one participant completed (each arm) and disclosing data could violate privacy interests. | Posted | 12 months |
|
|
| Other Pre-specified | Effect of Natalizumab on Questionnaire Derived Measures of Quality of Life | To explore changes in QoL measurements and the relations between these changes and those seen in ktrans and natalizumab serum levels. | Not Posted | 12 months | Participants |
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |